freelance
IT Quality Assurance Specialist Reference number: 1523
Last update: 16-10-2020, 12:02
Region: Heist-op-den-Berg
Sector: IT
6 months contract
Work experience: 3-5
Job description
We are looking for a specialist to control and approval of politices, procedures, acceptation criteria’s, qualification and document validation (plan, protocol, reports), indications of deviations for all computer systems related to:
Automation
Labo systems (camera’s, kartoneerders, MES, autoclaven, serialisatiesystemen ...),
Labo systemen (HPLC, GC, Empower, Lims , FTIR, NIR ...)
IT systemen (SAP, routers, servers, firewalls …)
What you’ll do
  • Assurance of the harmonized computer systems in projects where computer systems are involved.
  • Aligning with authors the comments with the review.
  • Give quality CSV input of deviation researches within validation (review of final reports, shut down of tasks in SAP)
  • Support to inspection and audits activities related to computer system questions
  • Promotion of GMP awareness and culture
  • Documents are written in Dutch and English
Required Skills
  • Strong affinity with IT as well as GMP standards.
  • Experience with Quality assurance and work review of GMP standards in the pharmaceutical industry.
  • Scientific background or knowledge acquired from experience in QA of cGMP environments
  • Analytical, organized, eye for detail, knowledge of MS Office
  • English and Dutch are a must
  • Knowledge of the following standards is a plus: GAMP5; ICH Q9/Q10; FDA/EU/WHO regulations on CSV (21CFR210/211/820/Part11; EU Vol4 annex11.
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